Orthopaedic device and method of use for treating bone fractures

ABSTRACT

Orthopaedic device and a method of use thereof are provided for treating a bone fracture. The orthopaedic device has at least one pressure applying element configured to apply pressure to soft tissue adjacent to the bone fracture and a holder configured to engage, in an engaged configuration, soft tissue adjacent to the bone fracture and, while in the engaged configuration, to permit adjustable positioning and securing the at least one pressure applying element to the holder.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 12/624,706 filed Nov. 24, 2009, the contents ofwhich are incorporated herein by reference.

FIELD OF THE INVENTION

The present disclosure is related generally to orthopaedic devices andmethods of use thereof, for treating bone fractures.

BACKGROUND OF THE INVENTION

Currently known devices for applying pressure to soft tissue surroundinga bone fracture include a relatively soft material such as a sponge thatis held against the soft tissue by a brace.

To use such devices, the sponge is positioned on the interior surface ofthe brace while the brace is in an untightened configuration so thatwhen the cross-sectional dimension of the brace is reduced, theresulting position of the sponge overlies the apex of the bone fracture.In response to the reduction in diameter of the brace, a distribution ofradially directed force is applied over the sponge and the spongethereby applies a distributed pressure to the soft tissue adjacent tothe bone fracture.

Such devices typically suffer from the drawback of requiring severaliterations of engagement and disengagement of the brace to suitablyadjust the magnitude of and the position at which pressure is applied tothe soft tissue. Further, it is difficult to maintain the pressureapplied to the soft tissue using such devices. Still further, theoperation of such devices are complex and not user-friendly. Stillfurther, they are limited to applying force to the soft tissues bymechanical means.

SUMMARY OF THE INVENTION

One embodiment of the invention includes an orthopaedic device fortreating a bone fracture. The orthopaedic device has at least onepressure applying element configured to apply pressure to soft tissueadjacent to the bone fracture, and a holder configured to engage, in anengaged configuration, soft tissue adjacent to the bone fracture and,while in the engaged configuration, to facilitate adjustable positioningand securing of the at least one pressure applying element to theholder.

Another embodiment of the invention includes a method of treating a bonefracture with an orthopaedic device having a holder and one or morepressure applying element, the method comprising configuring the holderinto an engaged configuration to engage soft tissue adjacent to the bonefracture, and while the holder is in the engaged configuration,adjustably positioning and securing at least one pressure applyingelement to the holder.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows an embodiment of the orthopaedic device that includes oneaccess port.

FIG. 2 shows an exploded view of the orthopaedic device of FIG. 1 with afoam pad.

FIG. 3 shows a cross sectional view of the device of FIG. 1 applyingpressure to the foam pad.

FIG. 4 shows a close up of a ratcheted strip.

FIG. 5 shows an embodiment of the orthopaedic device in an exploded viewwith two access ports and two foam pads.

FIG. 6 shows an embodiment of the orthopaedic device including aspring-loaded mechanism for applying a localized pressure to soft tissuesurrounding a fracture.

FIG. 7A shows an embodiment of the orthopaedic device with multipleaccess ports on the holder.

FIG. 7B shows an embodiment of the orthopaedic device with multiplecovered access ports.

FIGS. 8-10 show three embodiments of the orthopaedic device containingcapacitive coupling devices capable of applying two separate localizeddeforming pressure on soft tissue adjacent to a bone fracture.

FIGS. 11 and 12 show two embodiments of the orthopaedic devicecontaining magnetic coupling devices capable of applying a localizeddeforming pressure on soft tissue adjacent to a bone fracture.

FIGS. 13 and 14 show cross sectional views of two embodiments of theorthopaedic device including adjustable fluid or gas filled bladders.

FIGS. 15 through 18 show the orthopaedic device being applied to a legbone fracture with different holder configurations.

FIGS. 19 and 20 show an embodiment of the orthopaedic device forpositioning and maintaining a localized pressure over a bone fracture inan obese patient.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure is related to orthopaedic devices having at leastone pressure applying element configured to apply pressure to softtissue adjacent to a bone fracture and a holder configured, in anengaged state, to engage the soft tissue adjacent to the bone fractureand, while in the engaged state, to permit adjustable positioning of theat least one pressure applying element to the holder. The presentdisclosure is further related to methods of use of the orthopaedicdevices described herein to treat and align bone fractures and, inparticular, for accelerating the healing of bone fractures and/ormitigating the pain associated with bone fractures, through mechanismsdescribed in U.S. Pat. No. 5,171,310.

It is understood that soft tissue may include fat, muscle, facialtissue, small and large blood vessels, nerves lymphatic tissue and boneperiosteum.

It is generally known that fracture healing is affected by threephenomena, mechanical pressure, electric and magnetic fields.Mechanically applied pressure alters the blood flow in the soft tissues.This changes the tissue pH and thus the concentration of free calciumion is increased. Thus, increasing the pressure in the soft tissuesresults in an increase in the concentration of the free calcium ion. Anelectric field will result in an increase in the free calcium ionconcentration by the application of an electrically induced force on thesoft tissues. Additionally, an electrical field will impart a velocityto the free calcium ions. A magnetic field will also result in anincrease in the free calcium ion concentration by the application of amagnetically induced force to the soft tissues while the magnetic fieldwill impart a velocity to moving calcium ions. The present applicationdescribes devices and methods to apply one or more of the abovephenomena to align an angulated fracture and to manipulate (increase)the concentration of the free calcium ions around the fracture site toaccelerate its healing and mitigate pain.

Exemplary embodiments of the orthopaedic devices and methods of usethereof will be described with reference to the accompanying drawings.

First Embodiment

In a first embodiment, orthopaedic device 1, described below withreference to FIGS. 1-3, 5, 7A, 7B and 15-18, includes one or morepressure applying elements 16 and a holder 2.

The one or more pressure applying elements 16, to be described in detailbelow, is configured to be adjustably positioned on to the holder 2 andconfigured to adjustably apply pressure to the soft tissue adjacent tothe bone fracture.

The holder 2 is configured to be positioned onto a target body part andto engage soft tissue adjacent to a bone fracture. It is understood thatalthough the holder 2 is illustrated in the figures as a brace, theholder 2 may alternatively be a splint, a cast, a bandage, or astructural member that surrounds a body part, in whole or in part.

As illustrated in FIGS. 1 and 2, the holder 2 has, for example, a formedopen shell configuration along a longitudinal direction 3 that defines afirst edge 9 and a second edge 10. The open shell configuration of theholder 2 further defines longitudinal openings 4 at a first and secondend of the holder 2, as well as an inner surface 5 and an outer surface6. The holder 2 is configured to be of a length and width for encirclinga target body part in whole or in part therein. Further, the holder 2 issubstantially rigid in the longitudinal direction 3 and is thus suitedto laterally support the target body part and align an angulatedfracture.

As illustrated in FIGS. 15 and 16, the holder 2 may be constructed withmore than one formed open shell sections and/or annular sections so asto divide the holder 2 into two or more parts, which may be completelyor partially separated. Where the holder 2 is composed of two or moreparts, the parts can be configured such that, when engaged, the partssurround a target body part with one more bone fracture.

The holder 2 further includes a cross-sectional adjustment mechanism 7including, for example, an adjustable strap wound through a loop, a loopand hook material such as VELCRO® (see FIGS. 1 and 2), a locking orclipping mechanism, a snap-fit, a button, a lacing, a zipper, or aratcheted-type of mechanism, or any other type of mechanism known in theart.

The cross-section adjustment mechanism 7 can be operated to apply a hoopstress to holder 2 to reduce the cross-sectional dimension of the holder2 to thereby fit and secure the holder 2 to the target body part. Inthis engaged state, the holder 2 is further configured to facilitateadjustably positioning the one or more pressure applying elements 16 tothe holder 2 and to sustain the radially-directed pressure applied bythe one or more pressure applying elements 16 to the soft tissueadjacent to the bone fracture.

In a first example of the orthopaedic device 1 of the presentembodiment, the holder 2 includes an access port 8, which extendsthrough (i.e., through the outer surface 6 and through the inner surface5) of the holder 2. The access port 8 is configured to have a dimensionsuitable for permitting a pressure applying element 16 to operatetherethrough or to be adjusted therethrough to position and apply alocalized pressure onto soft tissue surrounding a bone fracture, eitherdirectly or through pressure applied to an intermediary contact material(described in further detail below) which then distributes the appliedpressure onto the soft tissue.

The access port 8 facilitates adjustment of the pressure applyingelement 16 through the access port 8 so the holder 2 need not be removedonce it is positioned and secured in an engaged state on a target softtissue. As illustrated in FIGS. 1 and 2, the access port 8 in theorthopaedic device 1 allows pressure to be applied and suitably adjustedin a localized manner from outside the holder 2 through the access port8 after the holder 2 has been fitted onto the target soft tissue.

The access port 8 disposed on the holder 2 can be of any suitable shape,which will permit a pressure applying element 16 to operatetherethrough. FIG. 2 shows the access port 8 as being circular in shape,but this is meant to be merely exemplary. The access port 8 can be anysuitable shape including, for example, oval, slot-shaped, square,rectangular or triangular.

The access port 8 renders the process of applying and adjusting alocalized pressure onto soft tissue adjacent a bone fractureconveniently accessible to a user and/or healthcare professional. Thepressure applying element 16 can be readily adjusted to maintain thepressure close to a set level. The pressure applying element 16 can alsopermit the user and/or healthcare professional to relieve the appliedpressure in the event that the applied pressure exceeds a comfort levelor other desired level.

Turning now to FIG. 5, in a second variation of the orthopaedic device1, the holder 2 may contain a plurality of access ports 8. The pluralityof access ports 8 is particularly beneficial for positioning one or morepressure applying elements 16 onto soft tissue of the affected bodypart. In particular, the plurality of access ports 8 can permit theselective use and/or adjustment of one or more pressure-applyingelements 16 at different locations of the holder 2 as shown in FIG. 7Awhere a pattern of access ports 8 are shown as disposed over the holder2.

With multiple access ports 8 located along the holder 2, the healthcareprofessional may surround the arm with the holder 2 having the multipleaccess ports 8 and then use one or more pressure-applying elements 16 toapply pressure where the healthcare professional desires it.

A uniform access port pattern such as the one shown in FIG. 7A isprovided on the holder 2 to allow almost any soft tissue pressureapplication to be achieved by the use of appropriate pressure-applyingelements 16. In this manner, the healthcare professional can have aholder 2 that includes multiple access ports 8 so the healthcareprofessional can first secure the holder 2 without requiring exactalignment of access ports 8 and use one or more pressure applyingelements 16 to achieve the desired pressure application pattern over thefracture area.

In FIG. 7A the access ports 8 are provided on the holder 2 in an openedconfiguration, however the present disclosure is not limited to thisconfiguration, and the access ports 8 can be covered with a coveringthat is removable. In FIG. 7B, the provided access ports 8 are initiallycovered with removable coverings 8B. Accordingly, when the holder 2 isplaced over the fracture, the healthcare professional may remove one ofthe coverings 8B to access the access port 8 beneath the covering 8B,and thus, introduce the pressure applying element 16 into the desiredaccess port 8, and keep the remaining access ports 8 covered or closed.

In a third variation where a substantial amount of pressure is to beintroduced over a specific portion of soft tissue, a group ofpressure-applying elements 16 can be applied to extend into one accessport 8 and to apply pressure to the particular portion of the softtissue surrounding a bone fracture.

Turning now to FIG. 3, there is shown a cross sectional view of theorthopaedic device, and in particular, the pressure applying element 16applying pressure to an intermediary contact material 8 a, through theaccess port 8, according to a fourth variation of the presentembodiment. In the orthopaedic device 1, an intermediary contactmaterial 8 a can be used to transmit the pressure asserted by thepressure applying element 16, and to distribute the pressure such thatthe soft tissue is not injured. The intermediary contact material 8 a,which is inserted between the pressure-applying device 16 and the softtissue, can be either detachably engaged or permanently attached to thepressure applying element 16 or the holder 2. The intermediary contactmaterial 8 a has a size and a construction that renders the pressureapplying element 16 capable of transmitting and distributing the appliedpressure onto the soft tissue. The pressure distribution can be eithernearly uniform or non-uniform on the contacting soft tissue surfaces.

The intermediary contact material 8 a can be constructed in whole or atleast in part of, for example, foam, a polyurethane, rubber, plastic,silicone, or any deformable material or any combinations thereof.Furthermore, the intermediary contact material 8 a may also containhollow compartments.

The intermediary contact material 8 a can be, for example, a disc-likefoam pad, as illustrated in FIGS. 2, 3 and 5. Alternatively, a foaminner lining 2 a arranged to the inner surface of the holder 2 can serveas an intermediary contact material 8 a to minimize direct contact ofthe hard shell structure of holder 2 with soft tissue and to distributepressure applied by the pressure applying element 16 onto the softtissue.

The thickness of intermediary contact material 8 a can be, dependent onthe material of construction, from a few millimeters to 1-2 cm or more.For example, generally, a thicker intermediary contact material is usedwith an orthopaedic device applied to a larger limb in order achieve thedesired pressure distribution.

In a fifth variation, the pressure applying element 16 or theintermediary contact material 8 a may include radiographic markers(i.e., a radiographically dense material) that can function as markersin an x-ray image in order to reveal the position and angle of thepressure applying element 16 relative to the bone fracture. X-ray imagescan be taken to determine the positioning of the pressure applicationarea relative to the fracture. Appropriate adjustments can then be madeto achieve proper positioning of the pressure application area.

It should be appreciated that the configuration of orthopaedic device 1and, in particular, holder 2 may vary depending on, for example, thetype, location and specific geometry of the bone fracture.

Method of Use

The orthopaedic device 1 described in the first and subsequentembodiments can be used in any suitable manner according to methodsunderstood in the healthcare profession to align and treat bonefractures such that the healing of a bone fracture can be improved andin particular, accelerated.

There are many factors which can determine how the orthopaedic device 1is used. Such factors include, for example, the type of fracture and thelocation of the fracture in the body. As an example, for an angulatedfracture, the orthopaedic device 1 can be configured to selectivelyapply localized pressure against the apex of the angulation in order toreduce the angulation over time while promoting healing of the bone. Incontrast, for a non-angulated type of fracture, for example, one fixedwith an intramedullary rod, the orthopaedic device 1 can be configuredto apply one or multiple points of localized pressure at the same timeor alternated over time for the biochemical effects.

As illustrated in FIG. 17, the orthopaedic device 1 and, in particular,the holder 2 can be configured to treat a simple or segmental fractures(a single bone fractured in two different sites, simultaneously). Theorthopaedic device 1, and in particular, the holder 2 can be configuredto treat, for example, a complete fracture, incomplete fracture, linearfracture, transverse fracture, oblique fracture, segmental fracture,compression fracture, spiral fracture, stress fracture or other bonefractures with other geometry.

It should also be appreciated that the orthopaedic device 1 and, inparticular, the holder 2 can be configured to be of a size suitable forencircling, in whole or in part, any body part. As illustrated in FIG.18, the orthopaedic device 1 and, in particular, the holder 2 can beconfigured to encircle body parts such as the torso in order to treatbone fractures in those parts of the body. Other bones of the body whichcan be treated by orthopaedic device 1 include, for example, thehumerus, radius, ulna, femur, tibia, fibula, clavicle, spine, pelvis,carpus, metacarpals, metatarsals, phalanx (for both hand and foot),talus, calcaneus, patella, scapula, sternum, and rib bones. In addition,the orthopaedic device 1 and, in particular, the holder 2 can beconfigured over the fractured part, to allow the pressure-applyingelement 16 to be positioned in proximity to and to treat fractureslocated on a diaphyseal, metaphyseal, proximal or distal portion of abone. In FIG. 18, the holder 2 is applied to the shoulder and strappedto the chest wall fixing it over the fractured clavicle. The access port8 a is then positioned over the fractured clavicle, allowing thepressure-applying element 16 to be positioned over the fracture.

It should also be appreciated that the orthopaedic device 1 can be usedin connection with other support structures.

The pressure applied by a pressure applying element 16 against softtissue can be any quantifiable amount of pressure that can acceleratethe healing of a bone fracture. For example, the applied pressure can besufficient to diminish local blood flow and thereby increase the localfree calcium ion concentration in the blood in soft tissues adjacent tothe bone fracture. In a first example, the applied pressure is anywherewithin the range of about 20 to about 100 mm Hg, and more typicallywithin the range of about 30 mm Hg to about 90 mm Hg. In a secondexample, the applied pressure is within the range of about 30 to about50 mm Hg. In a third example, the applied pressure is within the rangeof about 60 to about 90 mm Hg. In a fourth example, the applied pressureis within the range of about 30 to about 40 mm Hg. It should beappreciated that various applied pressure values/ranges anddistributions are within the scope of the present disclosure and thepresent disclosure is not limited to any specific pressure value/range.

The period of time that the applied pressure is retained on the softtissue may be as long as several days or may be very short, e.g., evenless than 0.5 minute, applied intermittently, for example in apulse-like manner. For example, the period of time can be the fullperiod of time that the orthopaedic device 1 is worn by the user or aportion of time that the orthopaedic device 1 is worn. The presentorthopaedic device 1 allows the amount of pressure and the intervals ofapplied pressure to be readily adjusted by the user.

Second Embodiment

In a second embodiment, an orthopaedic device 1 includes a holder 2 anda mechanical pressure applying element 16. The mechanical pressureapplying element 16 is supported by and/or connected to the holder 2 andis configured to apply and maintain a desired pressure directly againstthe soft tissue or indirectly against the soft tissue through anintermediary contact material 8 a.

FIG. 2 illustrates a first example of a mechanical pressure applyingelement 16 comprising a strip 14 that is relatively flexible butinextensible. The mechanical pressure applying element 16 furthercomprises locking/unlocking elements 15 disposed on the holder 2 atpositions adjacent to the access port 8 such that a length-adjustableportion of strip 14 spans across the access port 8. Thelength-adjustable portion of strip 14 that spans across the access port8 can be manipulated by the user into a convex shape in a directiontoward the soft tissue to apply pressure to the soft tissue. The strip14 can be arranged on the outer surface 6 of the holder 2 and bemanipulated by the user to protrude through the access port 8 to applypressure to the soft tissue. Alternatively, the strip 14 can be arrangedon the inner surface 5 of the holder 2 allowing the user to manipulatethe strip 14 through the access port 8. Both configurations facilitatethe positioning of strip 14 and setting a desired pressure withoutdisengaging the holder 2 from the soft tissue. Once a desired pressureis set, the strip 14 can be locked in place using locking/unlockingelements 15 to maintain the desired pressure for a desired period oftime. The locking/unlocking elements 15 can also be unlocked in order torapidly disengage the strip 14 in the event of discomfort, malfunctionor emergency.

The strip 14 can be of any suitable thickness and constructed of anysuitable material, which will permit the strip 14 to deform in bendingand apply and maintain a desired pressure for a desired time interval.For example, the strips 14 can be constructed of a suitable metal ormetal alloy, which contains enough rigidity to maintain a pressureagainst the soft tissue, while possessing enough flexibility to bend andbulge toward the soft tissue. Some examples of suitable metals includeiron-containing metals (e.g., steel), titanium, aluminum and alloys. Thestrip 14 can also be constructed of, for example, a sufficientlyflexible and inextensible plastic material or metal-plastic composite.

As illustrated in FIG. 5, in addition to the two locking/unlockingelements 15, the strip 14 may be fastened to holder 2 at one or more anadditional points 15 a. Such a configuration defines two lengthadjustable portions on the strip 14 that can be adjusted independently.Further, this configuration of strip 14 allows for selectively applyinga localized pressure onto one or two regions of soft tissue byeffectively bulging one or both length adjustable portions of the strip14.

The strip 14 can be of a width which is less than or equal to or evenlarger than the diameter of the access port 8. Alternatively, two ormore strips 14 can span across one or more access ports. Each of themultiple strips 14 can be individually and independentlylength-adjusted. Alternatively, the multiple strips 14 can be connectedso that adjustment of one strip 14 can affect other strips 14. In such aconfiguration, the strips 14 are disposed in a parallel manner to form awidth so that a smooth deforming surface (e.g., convex or biconvex)results.

In a second example, a mechanical pressure applying element 16 comprisesa ratcheted strip 14, as illustrated in FIG. 4. The ratcheted strip 14includes a number of ratcheting elements 17 that can be equally spacedfrom each other. The ratcheting elements 17 can be configured to engagewith an interlocking receiving element 15 to secure the ratcheted strip14 to apply a desired level of pressure to the soft tissue.

In a third example, a mechanical pressure applying element 16 comprisesa load-adjustable spring element 21, which is operatively connectedthrough an access port 8, between an intermediary contact material 8 a,which further contacts the soft tissue, and a plate 19, which is locatedon another end of the load adjustable spring element 21 opposite fromthe intermediary contact material 8 a, as illustrated in FIG. 6.

In FIG. 6, the plate 19 coupled to the load-adjustable spring element 21is operatively connected to the holder 2 by a screw and nut mechanism 18that can adjust the bias on the load-adjustable spring element 21.Tightening the nut of the mechanism 18 increases the load on theload-adjustable spring element 21. Loosening the nut of the mechanism 18decreases the load onto the load-adjustable spring element 21. Byincreasing the load on the load-adjustable spring element 21, thisspring state corresponds to an increased pressure on the soft tissueover the fracture, and decreasing the load on the load-adjustable springelement 21 corresponds to a decreased pressure on the soft tissue overthe fracture. It should be appreciated that instead of a load-adjustablespring element 21, another deformable element may be used.Alternatively, the body of the mechanical pressure applying element 16may be formed with threads and be screwed directly to the access hole 8which is provided with matching threads to receive the element 16,thereby avoiding the need for the screw and nut mechanism 18.

The load-adjustable spring element 21 described above can also beoperatively coupled to other pressure applying elements. For example,load-adjustable spring element 21 can be operatively coupled to a strip14. By adjusting the screw and nut mechanism 18, the plate 19 can bemoved to compress the load-adjustable spring element 21 against one ormore strip 14 through an access port 8. When the desired pressure isattained, the strip 14 can be locked in place with locking/unlockingelement 15 to maintain the applied pressure.

In a fourth example, the adjustable pressure applying element 16comprises a bladder 8C containing a liquid, gas or a solidifiableliquid.

As illustrated in FIG. 14, the bladder 8C can be connected to a valve 8Dto introduce air (gas) or liquid via pump 8E, and can be supported withor connected to the inner surface 5 of the holder 2. The use of air(gas) in a relatively elastically expandable bladder 8C allows for themaintenance of a relatively uniform and constant pressure over the softtissue. The bladder 8C can also be configured to be accessible throughan access port 8. The fluid-filled bladder 8C is capable of beingshaped, i.e., molded in form, through the access port 8 to protrudetoward the soft tissue.

FIG. 13 shows a solidifiable liquid 8F introduced into bladder 8C. Uponestablishing a desired pressure within bladder 8C against the softtissue, the solidifiable liquid 8F is capable of changing into a rigidsolidified form within a short period of time (e.g., in less than 1minute).

The solidifiable liquid 8F can be any liquid known in the art capable ofsolidifying at room temperature in response to a stimulus. The stimuluscan be, for example, a mixture of two portions of a mixture to commencea chemical reaction, which changes the solidifiable liquid 8F into asolid. The solidifiable liquid 8F should be capable of maintaining arigid solid form either after removal of the stimulus or by intermittentor continued application of the stimulus. Alternatively, the stimuluscan be an electrical charge or magnetic field supplied to a mixture tosolidify the mixture.

The solidifiable liquid 8F can be, for example, a magnetorheologicalfluid. A magnetorheological (MR) fluid 8F is a type of fluid, which isconverted to a highly viscous form or solid when stimulated by amagnetic field of appropriate strength. A MR fluid 8F is typicallycomposed of micrometer or nanometer-sized magnetic particles(paramagnetic colloidal particles) suspended in a viscous medium, suchas oil. The particles can be, for example, of an iron or magnetic ironoxide composition.

The disclosure also contemplates adjusting the magnetic field strengthin order to vary the rigidity of the solidifiable fluid 8F in bladder 8Csuch that during exercise the pressure transmitted by the bladder 8Conto the soft tissue can be varied. Since a MR fluid requires the use ofa magnetic field, the orthopaedic device 1 may also include a device inthe holder 2 for providing a magnetic field. For example, appropriatelysized electromagnetic coils can be included for this purpose.

Alternatively, the solidifiable liquid 8F can be an electrorheologicalfluid. An electrorheological (ER) fluid is a type of fluid which isconverted to a highly viscous form or solid when stimulated by anelectrical field (typically several kV/mm). An electrorheological fluidis typically composed of fine non-conducting (dielectric) particles(e.g., up to 50 microns in diameter) in an electrically insulatingfluid. An example of an ER fluid 8F is corn flour suspended in an oil,such as a vegetable oil or silicone oil. The ER fluid 8F consideredherein also include the more recent giant electrorheological (GER)fluids, which are typically able to sustain higher yield strengths atlower electrical fields. An example of a GER fluid 8F is a compositioncontaining urea-coated nanoparticles of barium titanium oxalatesuspended in silicone oil. The disclosure also contemplates adjustingthe electric field strength in order to vary the rigidity of thesolidifiable fluid 8F in bladder 8C such that during exercise thepressure transmitted by the bladder 8C onto the soft tissue can bevaried. Since an ER fluid 8F requires the use of an electric field, thedisclosure also contemplates including a device in the holder 2 forproviding an electric field. For example, appropriately sized electrodes(charged plates) along with an electrical power source can be includedfor this purpose.

It should be appreciated that other mechanical pressure applyingelements 16 can be used with the present disclosure. The above describedembodiments are advantageous in that the pressure applied to the softtissue can be adjusted and maintained without requiring removal ordisengagement of the holder 2 from the body part.

Third Embodiment

A third embodiment is described below with reference to FIGS. 8-10.

FIG. 8 illustrates a cross-sectional view of an orthopaedic device 1that includes a capacitive coupling device as a pressure applyingelement 16 for applying a soft tissue deforming pressure onto softtissue adjacent to a bone fracture to treat and accelerate healing ofthe fracture.

The capacitive coupling device includes a first electrically-conductivefoil element 23, having two foil portions 23 a and 23 b, and a secondelectrically-conductive foil element 24 that are positionedapproximately opposite to each other on a holder 2. Foil elements 23 and24 can be positioned or secured to the holder 2, for example, throughaccess ports 8, such that a user can designate the positions of the foilelements 23, 24 on the holder 2 after the holder 2 is engaged to thesoft tissue adjacent to the bone fracture.

The foil elements 23, 24 are electrodes and are designed such that foilelements 23, 24 can assume an electrical charge with portions 23 a, 23 bbeing positive and foil element 24 being negative.

The foil portions 23 a and 23 b are electrically interconnected to oneanother and contain the same charge. The foil portions 23 a and 23 binclude a positive charge and thus repel from one another. The portion23 b is configured to be connected to the holder 2 to remain stationary,thereby allowing the portion 23 a to repel away from portion 23 b and toapply a pressure onto soft tissue when the portions 23 a and 23 b arecharged.

The foil portion 23 a can optionally contact an intermediary contactmaterial to distribute the pressure applied by the foil portion 23 tothe soft tissue adjacent to the bone fracture.

By modulating the electrical charge between the foil elements 23 a and23 b, the amount of deflection of the foil portion 23 a can be adjusted.Preferably, the foil portions 23 a, 23 b can be coupled to a controller(not shown) to permit the user to regulate the current passing throughthe foil portions 23 a, 23 b, and thus further adjust the amount ofpressure on the fracture. For example, the controller can regulate thecurrent passing through the foil portions 23 a, 23 b in an on-offpattern or other intermittent profile pattern of choice.

The foil portions 23 a, 23 b are constructed of any conductive materialknown in the art. Specifically, the foil portions 23 a, 23 b areconstructed of resilient material which can apply and hold a suitablesoft tissue deforming force on the fracture. Some examples of suitablematerials for the foil portions 23 a, 23 b include various conductivemetals (e.g., copper, silver, iron, and alloys or layered structures),and conductive polymers or plastics.

Alternatively, the foil portions 23 a and 23 b of like charge are notsplit from a common electrode as described in FIG. 8, but rather can bealternatively formed from two separate foil electrode 23 a and 23 b oflike charge, with one foil electrode 23 b attached to the inner surface5 of the holder 2 and another electrode 23 a being spaced away and incontact with the soft tissue and fracture to apply pressure to thefracture as shown in FIG. 9. The two separate foil electrodes 23 a and23 b can be made to assume the same charge by, for example' beingconnected to the same terminal of a battery, or by being connected toterminals of different batteries wherein the different terminals are ofthe same polarity.

The above described configuration of foil elements 23, 24 provides anadditional benefit of directing calcium ions 25 toward the bone fractureby charge repulsion. In the above described configuration, an electricalpotential 27 is created between foil elements 23, 24 such that calciumions are directed away from the positive charged foil element 23 towardthe negatively charged foil element 24. By positioning the deformingfoil portion 23 a against the fracture side of a bone, the calcium ionsare directed toward, and thus concentrated at, the fracture site.

Turning now to FIG. 9, there is shown an alternative embodiment of thepresent disclosure wherein foil elements 23, 24 are positioned on aholder 2, with each foil element 23, 24 having two foil portions 23 a,23 b, 24 a, 24 b, respectively. In this configuration, pressure can beapplied at two regions of the soft tissue adjacent to the bone fracturefrom approximately opposite directions. This configuration may beadvantageous in the instance whereby a fracture includes a specificgeometry, and whereby the pressure and the electric field is applied tothe body part from at least two different directions and can be adjustedto the desired level, independently.

Turning now to FIG. 10, in an alternative variation, a plurality ofpositively charged foil elements 23, each having a pair ofinterconnected foil portions is arranged on a holder 2 relative to anegatively charged foil element 24. Such a configuration provides theorthopaedic device 1 with the ability to apply localized pressuresimultaneously or alternately in at least two or more differentlocations of the soft tissue adjacent to the fracture for complexfracture shapes to accelerate healing of the fracture.

In another variation, the applied pressure can be modulated by thecharge supplied to the desired foil elements 23 a, 23 b, 24, whichmodulates the field strength developed in the body part between thecharged foil elements 23 a, 23 b, 24. For example, increasing a voltagebetween opposing foil elements 23 a, 23 b and 24 can increase the amountof applied pressure while decreasing a voltage between opposing foilelements 23 a, 23 b, and 24 can decrease the amount of applied pressure.Various amounts of charging can be supplied to the electrode foilelements and various charging configurations are possible and are withinthe scope of the present disclosure. Various charging patterns,including intermittent charging patterns, are therefore possible toapply to achieve various applied pressure levels and/or electric fieldstrength levels and all such patterns are within the scope of thepresent disclosure.

The amount of voltage necessary to produce a sufficient level of chargein foil elements 23 a, 23 b, and 24 in order to produce a desired amountof localized pressure can all be readily calculated. For example, if thedesired pressure (P) is known, the corresponding force (F) can becalculated by multiplying P by the area of contact of the contactingfoil element 23 a, 23 b. Since F is the sum of the repulsive force F₁(i.e., between 23 a and 23 b) and the attractive force F₂ (i.e., between23 b and 24), F₁ and F₂ can be adjusted to arrive at the desired F.Coulomb's Law can be used to calculate the appropriate levels of chargerequired to adjust F₁ and F₂ in order to achieve a desired F. Forexample, by Coulomb's Law:

-   -   F₁=1/4πε₀(q₁×q₂/r₁₂ ²) for the repulsive force, wherein r₁₂ is        the distance between diverted foil elements 23 a and 23 b, and        q₁ and q₂ are the amounts of charge on each respective foil        element 23 a and 23 b; and

F₂=1/4πε₀(q₂×q₃/r₂₃ ²) for the attractive force, wherein r₂₃ is thedistance between diverted foil elements 23 b and 24, and q₂ and q₃ arethe amounts of charge on each respective foil element 23 b and 24.

Using the above equations, appropriate charging values q₁, q₂, and q₃can be found in order to provide a force F that can provide a pressureP. The charging values can be realized by selection of an appropriatevoltage, wherein the optimal voltage can be calculated. Alternatively,the voltage necessary to produce a given soft-tissue deforming pressurecan be found experimentally by observing the amount of pressure appliedper amount of voltage.

The orthopaedic device 1 can include any suitable device for applying avoltage onto the foil elements 23 a, 23 b and 24. For example, theorthopaedic device can include a suitable electrical charging device,such as provided by a lithium-ion rechargeable battery, a plug inelectrical connection, a nickel hydride battery, a renewable source,like a solar cell or another electrical source, such as a smallelectrical generator with a stator and rotor. The orthopaedic device 1can also include battery connection ports and conductive leads (notshown).

Fourth Embodiment

A fourth embodiment is of orthopaedic device 1 comprising a holder 2 anda magnetic device as pressure applying element 16 connected to theholder 2 for applying a soft-tissue deforming pressure onto soft tissueadjacent to a bone fracture is described below with reference to FIG.11.

The magnetic device includes a magnetic source 28 operating (e.g.,attached) on a first side of the holder 2 and a flexible permanentmagnetic strip element 29 associated with the magnetic source 28positioned through an access port onto the holder 2.

In one configuration, the magnetic source 28 is an electromagnetic coilcoupled to a power supply. The magnetic source 28 is capable ofproducing an adjustable magnetic field by modulation of the appliedcurrent to the electromagnetic coil. The flexible permanent magneticstrip element 29 is positioned through an access port on to the holder 2and is operatively connected, for example, to the inner surface 5 of theholder 2 such that at least a portion of the permanent magnetic stripelement 29 can protrude toward and apply pressure to a region of thesoft tissue adjacent to the bone fracture when the magnetic source 28 isactivated. The flexible permanent magnetic strip element 29 can beattracted or repulsed toward the soft tissue by inducing a magneticfield from the magnetic source 28, which can be the same polarity as theside of the flexible permanent magnetic strip element 29 facing themagnetic source 28. The like magnetic polarities may repel each otherand cause the flexible permanent magnetic strip element 29 to protrudetoward the body part, or alternatively, the opposite magnetic polaritiescan cause the flexible permanent magnetic strip 29 to move away from thefracture to reduce the applied pressure to the soft tissues surroundingthe fracture.

It should be appreciated that an intermediary contact material (ex. foampad 8 a) can be positioned between the soft tissue and the flexiblepermanent magnetic strip 29 to distribute force to the soft tissue.

The flexible permanent magnetic strip 29 is constructed of any material,which is permanently magnetic, and of a suitable resilient construction(including thickness and composition) which renders the flexiblepermanent magnetic strip 29 capable of applying and holding a suitablesoft-tissue deforming force. Some examples of suitable materials for themagnetic strip 29 includes any of the magnetic compositions known in theart (e.g., magnetite, cobalt, nickel, ceramic magnets, alnico, ticonal,rare earth magnets (e.g., samarium-cobalt and neodymium-iron-boron (NIB)magnets), combinations thereof, coatings thereof, and layered andnon-layered composites thereof.

Turning now to FIG. 12, there is shown an alternative configuration withat least two magnetic sources 28, 30 to manipulate and adjust the amountof pressure the flexible permanent magnetic strip 29 applies to the softtissue adjacent to the bone fracture. The second magnetic source 30 isdisposed substantially opposite the first magnetic source 28. It shouldbe appreciated that this positioning is illustrative and may changedepending on the orientation of the fracture. The second magnetic source30 operates on a second side of the holder 2 and approximately oppositeto the first side; however, the magnetic sources 28 and 30 may be placedin any desired location relative to the fracture. Each of the first andsecond magnetic sources 28 and 30 produce magnetic fields. The twomagnetic sources 28 and 30 work together to promote the bulging of theflexible magnetic strip 29 to apply pressure to the soft tissue and thefracture. Specifically, the switchable magnetic source 28 repels theflexible magnetic strip 29, while the switchable magnetic source 30attracts the flexible magnetic strip 29.

It should be appreciated that the orthopaedic device 1 is not limited toa single magnetic strip 29 as show in FIGS. 11 and 12, and may have atleast two strips 29. The number of magnetic strips 29 may depend on thefracture and geometry of the fracture. It should also be appreciatedthat the magnetic strip 29 is not limiting to one bending or bulgingcurved portion that contacts the tissue but depending on the polarity,the magnetic strip 29 can have more than one bulging or more than onecurved surface. For example, a magnetic strip 29 can be connected to theconcave inner surface 5 of the holder 2 in more than two locations suchthat more than one bulging section on the strip 29 can result. Theholder 2 can apply localized pressure simultaneously or in differentlocations of the body part adjacent to the fracture to accelerate thehealing. For example, the pressure can be adjusted by the selectiveoperation of the magnetic sources 28, 30 by modulating the magneticfield or the current supplied to the coil.

The applied pressure is modulated by the magnetic field strength appliedonto the flexible magnetic strip 29. For example, increasing themagnetic field strength can increase the amount of applied pressure,while decreasing the magnetic field strength can decrease the amount ofapplied pressure. The intensity of the magnetic field necessary toproduce a sufficient attractive/repulsive force between the desired coil28 or 30 and the magnetic strip 29 can be changed to produce a desiredamount of pressure. Various magnetic field strength patterns, includingintermittent charging patterns, are therefore possible to apply toachieve various applied pressure levels and/or magnetic field strengthlevels and are within the scope of the present disclosure.

A benefit of the magnetic field produced by the sources 28 or 30 is theability to favorably influence calcium ions at the fracture site. Forexample, a magnetic field will concentrate the calcium ions in thecompressed region because they are deflected by the magnetic fieldtoward the fracture site. Such a magnetic field causes the calcium ionsflowing in blood vessels near the fracture to follow circular paths ofradius r=mv/qB, where m is the mass of the calcium ion, V is itsvelocity, q is its charge, and B is the applied magnetic field. Bymanipulating the intensity of the magnetic field, the trajectory of thecalcium ions can be manipulated to congregate in the blood vesselssurrounding the fracture. Because the flexible magnetic strip element 29is intimate with soft tissues over the fracture, this effect ismaximized. This increased concentration of calcium ions will furtheraccelerate healing of the fracture.

The amount of magnetic field strength necessary to produce a suitabledeforming force may depend on the size and construction of the flexiblemagnetic strip 29 as well as other factors. For example, if the desiredpressure (P) is known, the corresponding force (F) can be calculated bymultiplying P by the area of contact of the flexible magnetic strip 29.Since F is the sum of the repulsive force F₁ (i.e., between 28 and 29)and the attractive force F₂ (i.e., between 29 and 30), F₁ and F₂ can beadjusted to arrive at the desired F. To calculate the appropriatemagnetic field required to adjust F₁ and F₂ in order to achieve adesired F, the equation F=A*B²/2*μ° can be used, wherein F is force inNewtons, A is the surface area of the mat and coil in meter², B is thestrength of the magnetic field in weber/meter², and μ° is the magneticpermeability constant. For example, to apply about 30 mm Hg pressure(about 400 dyne/cm) to the soft tissues by a 10 cm by 10 cm magneticstrip 29, a magnetic field of 0.01 weber/meter² (i.e., approximately 100Gauss) can be used. When there is separation of the magnet source oflength L by distance x, the Force F can be represented asF=B²*A²(L²+R²)/(Π μ° L² [1/x²−1/(x+2L)²−2/(x+L)²] wherein R is theradius of the magnet or coil 28. Various coil 28, 30 and magnetic strip29 size configurations are possible and within the scope of the presentdisclosure.

The orthopaedic device 1 can include a suitable electrical power supplyfor creating a magnetic field in the electromagnetic coils 28 and 30.For example, the orthopaedic device 1 can include a battery or otherelectrical source for this purpose, such as a photovoltaic solar cell, acapacitor, an ultra-capacitor, a lithium ion battery, a nickel hydridebattery, an electric generator including a rotor and a stator or a plugfor coupling the electromagnetic coils 28 and 30 to an electricalhousehold power supply line.

The orthopaedic device 1 can also include features (not shown) forconnecting the power supply with the holder 2 and the magnetic device 28and 30. In one configuration, at least one of the magnetic sources 28and 30 and the permanent magnetic strip element 29 are detachablyengaged with the holder 2 using a suitable detachable connector, suchas, a clip, a removable connector engaged in an engageable slot orgroove located in or on the holder 2. In another configuration, at leastone of the magnetic sources 28 and 30, and the permanent magnetic stripelement 29 can be fixedly attached to the holder 2. An intermediarycontact material can be connected to the permanent magnetic stripelement 29 or may be placed between the soft tissue and the permanentmagnetic strip element 29 to distribute the pressure along the softtissue and fracture to accelerate the healing.

Fifth Embodiment

The holder 2 may further include a pressure indicator to provide aquantifiable indication of the pressure being applied to the soft tissueand the fracture. The pressure indicator (not shown) may provide anindication to a user that a suitable pressure has been achieved toaccelerate the healing of the fracture or when a desired pressureagainst soft tissue has been reached, or alternatively that the pressureshould be increased/reduced.

In one configuration of the pressure indicator, an auditory indicatorcan sound to indicate that the desired pressure has been reached.

In another configuration of the pressure indicator, a visual-basedindicator can display, for example, numbers, colors, or both, toindicate a certain degree of applied pressure. The visual-basedindicator is based on a mechanism whereby as the strip 14 is presseddown to exert pressure to the surface of the body the force exerted onthe locking ends 15 would be utilized to indicate the pressure appliedto the body surface. This can be accomplished, for example, by attachingat least one of the locking ends to the holder 2 by a relatively stiffspring. The extension/contraction of the spring will then indicate theamount of force being transferred to the holder 2, thereby the pressureexerted to the body surface. A coloring or marking means can also beused as a scale to indicate the level of pressure applied to the bodysurface.

In another configuration, a similar type of mechanism is applied to aspring element 21 described above with regard to FIG. 6, wherein aflexible strip with pressure-indicating marks is overlaid onto orconnected to the spring element 21. The compression and expansion of thespring element 21 causes the pressure-indicating flexible strip (notshown) to move in a like manner. A pressure-indicating mark on theflexible strip, when visible, thus indicates the applied pressure for agiven compression of the spring element 21.

In yet another configuration, the visual-based indicator can operate byuse of a material or combination of materials, which exhibit a change incolor when a pressure change occurs. Various indicator configurationsare possible and within the scope of the present disclosure.

Sixth Embodiment

A sixth embodiment is described below with reference to FIGS. 19 and 20.

In the particular case of a morbidly obese patient, a specialarrangement may be necessary to keep a localized pressure in place overa fracture since the weight of a limb or other body part may interferewith positioning of holder 2 (e.g., a brace or sling). A fracture ofthis type in an obese patient can be difficult to control with a singlepositioning device, such as a holder 2. A holder 2 alone typicallycannot generate enough force to overcome the weight of the limb distalto the fracture. The use of an additional positioning device, such as asling 100 or a pillow 105, is often helpful.

For example, in some morbidly obese patients, a humeral fracture canangulate over the torso, particularly when the fracture is in itsmid-third and is unstable, i.e., transverse. In one configuration, asdepicted in FIG. 19, this particular situation can be remedied by usinga holder 2 (preferably, a BIO-CHEM BRACE) in the upper extremity incombination with an additional shoulder sling 100 for further support.In addition, an abdominal pillow 105 can be attached to the sling 100 tomaintain the elbow away from the torso, as also shown in FIG. 20.Together, the holder 2 and the sling 100 together can supply the forcesneeded to maintain the localized pressure over the fracture.

Seventh Embodiment

An intermediate contact material such as 8A in FIG. 2 of the appropriatesize, shape, thickness and density can be inserted above or below theelectrical foil 23A in FIGS. 8-10 to achieve the desired pressure. Thismay require the holder 2 to be disengaged.

It is appreciated that the foil 23A may be used to apply the electricfield without the need for charged foil elements 23 b or 24. Thisembodiment allows different application schedules for the mechanicalapplied pressure, electrically applied pressure and the electric field.

Eighth Embodiment

An intermediate contact material such as 8A in FIG. 2 of the appropriatesize, shape, thickness and density can be inserted above or below theflexible permanent magnetic strip element 29 in FIGS. 11-12 to achievethe desired pressure. This may require the holder 2 to be disengaged.

It is appreciated that the flexible permanent magnetic strip element 29may be used to apply the magnetic field without the need for magneticsource elements 28 and 30. This embodiment allows different applicationschedules for the mechanical applied pressure, magnetically appliedpressure and the magnetic field.

Ninth Embodiment

An intermediate contact material such as 8A in FIG. 2 of the appropriatesize, shape, thickness and density can be inserted above or below theelectrical foil 23A and the flexible permanent magnetic strip element29, to achieve the desired pressure. This may require the holder 2 to bedisengaged.

It is appreciated that the electrical foil 23A and the flexiblepermanent magnetic strip element 29 may be used to apply both anelectric and magnetic field without the need for charged foil elements23 b or 24 or the magnetic source elements 28 and 30. This embodimentallows different application schedules for the mechanical appliedpressure, electrically and magnetically applied pressure and electricaland magnetic field.

Numerous modifications and variations of the present invention arepossible in light of the above teachings without departing from thespirit or scope of the invention. It is therefore to be understood thatwithin the scope of the appended claims, the invention may be practicedotherwise than as specifically described herein.

1. An orthopaedic device for treating a bone fracture, the orthopaedicdevice comprising: at least one pressure applying element configured toapply pressure to soft tissue adjacent to the bone fracture; and aholder configured to engage, in an engaged configuration, soft tissueadjacent to the bone fracture and, while in the engaged configuration,to facilitate adjustable positioning and securing of the at least onepressure applying element to the holder.
 2. The orthopaedic deviceaccording to claim 1, wherein each of the at least one pressure applyingelement is configured to adjustably apply radially directed pressure tothe soft tissue adjacent to the bone fracture.
 3. The orthopaedic deviceaccording to claim 1, wherein the holder includes an adjustmentmechanism configured to bring the holder into the engaged configurationand to sustain radially directed pressure applied by the at least onepressure applying element.
 4. The orthopaedic device according to claim1, wherein the holder includes at least one access port extendingthrough the holder to facilitate adjustable positioning and operation ofthe at least one pressure applying element within an engagedconfiguration of the holder.
 5. The orthopaedic device according toclaim 4, wherein the at least one access port is configured to have adimension suitable for permitting a pressure applying element to operatetherethrough or to be adjusted therethrough to position and apply aradially directed pressure to the soft tissue adjacent to a bonefracture.
 6. The orthopaedic device according to claim 4, wherein the atleast one access port is provided in a uniform pattern on the holder. 7.The orthopaedic device according to claim 4, wherein the holder includesat least one cover configured to removably cover the at least one accessport.
 8. The orthopaedic device according to claim 1, the orthopaedicdevice further comprising at least one intermediary contact materialthat is attached to one of the at least one pressure applying elementand configured to transmit and distribute the radially directed pressureapplied by the at least one pressure applying element to the soft tissueadjacent to a bone fracture.
 9. A method of treating a bone fracturewith an orthopaedic device having a holder and at least one pressureapplying element configured to apply pressure to soft tissue adjacent toa bone fracture, the method comprising configuring the holder into anengaged configuration to engage soft tissue adjacent to the bonefracture; and while the holder is in the engaged configuration,adjustably positioning and securing the at least one pressure applyingelement to the holder.
 10. The method of treating a bone fractureaccording to claim 9, the method further comprising operating the atleast one pressure applying element to adjustably apply radiallydirected pressure to the soft tissue adjacent to the bone fracture. 11.The method of treating a bone fracture according to claim 9, wherein thestep of configuring the holder into an engaged configuration comprisesoperating an adjustment mechanism of the holder to bring the holder intothe engaged configuration to sustain subsequent application of radiallydirected pressure by the at least one pressure applying element.
 12. Anorthopaedic device for treating a bone fracture, the orthopaedic devicecomprising: at least one pressure applying element configured to applypressure to soft tissue adjacent to the bone fracture; a holderconfigured to engage, in an engaged configuration, soft tissue adjacentto the bone fracture and, while in the engaged configuration, tofacilitate adjustably positioning and securing the at least one pressureapplying element to the holder; and a magnetic source operativelyarranged to the holder to produce an adjustable magnetic field in thevicinity of the soft tissue adjacent to the bone fracture.
 13. Anorthopaedic device for treating a bone fracture, the orthopaedic devicecomprising: at least one pressure applying element configured to applypressure to soft tissue adjacent to the bone fracture; a holderconfigured to engage soft tissue adjacent to the bone fracture and tosecure the at least one pressure applying element to the holder; atleast one foil element configured to provide an adjustable electricfield in the vicinity of the soft tissue adjacent to the bone fracture.14. An orthopaedic device for treating a bone fracture, the orthopaedicdevice comprising: at least one pressure applying element configured toapply pressure to soft tissue adjacent to the bone fracture; a holderconfigured to engage soft tissue adjacent to the bone fracture and tosecure the at least one pressure applying element to the holder; and amagnetic source operatively arranged to the holder to produce anadjustable magnetic field in the vicinity of the soft tissue adjacent tothe bone fracture.